Public interest groups, which moved the Supreme Court over the unethical
trial of HPV vaccine by PATH, have sought re-examination of the
current ethical and legal framework to conduct drugs/vaccine trials in
India to secure stronger protections for human subject participants.The
groups-- SAMA, a resource group for women and health, Locost, Drug
Action Forum, Karnataka and Delhi Science Forum – also claimed that the
existing laws proved to be inadequate to protect the subject
participants.The NGOs, armed with the report of the
Parliamentary Standing Committee on the matter, alleged that violation
of the right to health of thousands of young girls happened during the
unethical conduct of HPV vaccine in Andhra Pradesh and Gujarat, between
2009 and 2010 by PATH in collaboration with the ICMR.The bench
consisting Chief Justice P Sathasivam and Justice Ranjan Gogoi on Monday
had issued the notice to the Centre and others on the petition. The
matter had been tagged along with another pending case on the topic and
would now come up for hearing on December 6.The spokespersons
for the NGOs said they approached the court on behalf of thousands of
young girls who were made to participate in vaccinate trials done
without strong ethical or legal safeguards to protect their rights.Apart
from addressing the doubtful claims about the safety and efficacy of
the vaccines involved, the NGOs have also sought to hold PATH and others
liable for their illegal actions under the current ethical, penal and
regulatory framework to protect subject of biomedical research provided
under Schedule Y of the Drugs and Cosmetics Rules, 1945 and the Good
Clinical Practice Guidelines and ICMR Guidelines, which has led to the
violation of the right to health of thousands of young girls involved in
the vaccine trials.All material on record sufficiently refutes
the claims of the ICMR and PATH that the trial was a study. In fact, the
permission to import the vaccines had been granted by the DCGI on the
condition that data on adverse events generated from the clinical trials
would be submitted to him, according to the affidavit filed by the
petitioners.Even though the study protocols of the PATH had
several flaws that could result in the violation of the rights of the
participants to these trials they were given ethical approval by the
Ethics Committees. They were not questioned on their choice to conduct
the study with young girls who belong to socio-economically backward
families, many of whose parents could not read or write nor did they
ensure that the required standard of medical care would be available to
the trial participants as a result of which many girls who possibly
suffered serious adverse events related to the trial, died, it said.“Violations
in obtaining informed consent from the young girls were recorded by
independent fact-finding teams as well as the recently released 72nd
Report of the Parliamentary Standing Committee. The respondents abused
their position of authority by authorizing hostel wardens and
headmasters to provide informed consent on behalf of the girls. Many
other discrepancies were found including insufficiency of information on
the risks and alternatives to the vaccines in the consent forms as well
as inconsistencies between signatures and names of the persons signing
on behalf of the minors. Many of the girls and their parents had no
knowledge about what the vaccine was for and some even considered it to
be part of the Universal Immunization programme since the National Rural
Health Mission (NRHM) logo was printed on the vaccination cards,” the
affidavit said.
Source:Pharmabiz
Source:Pharmabiz
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